Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract - Tabular View

Tracking Information

First Received Date ^ICMJE

March 6, 2003

Last Updated Date

July 23, 2008

Start Date ^ICMJE

March 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00055666 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

Official Title ^ICMJE

Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease

Brief Summary

RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract.

PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.

Detailed Description

OBJECTIVES:

Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.
Minimize the serious side effects associated with systemic steroid use in these patients.

OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.

PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Open Label

Condition ^ICMJE

Graft Versus Host Disease

Intervention ^ICMJE

Drug: beclomethasone dipropionate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract
- Failed standard therapy with or has a contraindication to systemic immunosuppressive agents
No clinically significant intestinal infection (confirmed by stool culture)
No persistent vomiting of all oral intake
Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol

PATIENT CHARACTERISTICS:

Age

4 to 70

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Able to swallow medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics

Radiotherapy

Not specified

Surgery

Not specified

Gender

Both

Ages

4 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00055666

Responsible Party

Study ID Numbers ^ICMJE

CDR0000270747, RPCI-DS-01-04

Study Sponsor ^ICMJE

Roswell Park Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Philip L. McCarthy, MD

Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP